Research to be presented on Orencia,
deucravacitinib and pipeline assets highlights breadth of data and
focus on transforming treatment paradigms for people living with
rheumatic diseases
Bristol Myers Squibb (NYSE:BMY) today announced data from 29
company-sponsored presentations across Orencia, deucravacitinib and
pipeline assets will be presented at the American College of
Rheumatology (ACR) Convergence 2021, taking place virtually
November 3-10, 2021.
Research at the meeting includes 17 company-led presentations
supporting Orencia’s established clinical profile. These data
include:
- Post hoc analysis of the ASCORE study in rheumatoid arthritis
(RA) demonstrated that several baseline characteristics were
associated with remission in patients with RA treated with
subcutaneous Orencia. In the study, patients with seropositive RA,
no previous biologic disease-modifying antirheumatic drug use,
low HAQ-disability index and low BMI at baseline were more likely
to achieve Disease Activity Score 28 (DAS28), Simplified Disease
Activity Index (SDAI) and Clinical Disease Activity Index (CDAI)
remission when treated with Orencia; seropositivity was associated
with remission regardless of Orencia treatment line (abstract
number 1228).
- Health economics outcomes research of seropositive RA Medicare
beneficiaries showed that among Medicare beneficiaries with
seropositive RA, those on Orencia were more often persistent to
their index treatment and had longer time to treatment
discontinuation at one year compared to patients on tumor necrosis
factor inhibitors or Janus kinase inhibitors.
“At ACR Convergence 2021, our studies deepen our understanding
of Orencia as an important treatment for people living with
moderate-to-severe rheumatoid arthritis and highlight the potential
of deucravacitinib in treating immune-mediated rheumatic diseases,"
said Jonathan Sadeh, M.D., M.Sc., senior vice president of
Immunology and Fibrosis Development, Bristol Myers Squibb. “We look
forward to presenting our data, demonstrating our ongoing
commitment to the rheumatology research community. With our robust
rheumatology portfolio, Bristol Myers Squibb continues to expand
upon the foundation in rheumatology established over 20 years ago
and are following the science to deliver the next wave of
immune-modulators and precision medicines.”
Bristol Myers Squibb will also present six abstracts from the
Phase 2 study of deucravacitinib, a first-in-class, oral, selective
tyrosine kinase 2 (TYK2) inhibitor, in patients with active
psoriatic arthritis. These data continue to shed light on the
expected clinical profile of deucravacitinib and the
pharmacodynamics of key biomarkers involved in the pathogenesis of
the disease. These data include:
- Biomarker analyses from a Phase 2 study that showed
deucravacitinib suppressed blood biomarkers of the IL-23/IL-17 and
IFN-1 pathways and key markers of joint damage, concomitant with
clinical symptom improvements in patients with psoriatic arthritis
in comparison with placebo (abstract number 0490). There were no
clinically meaningful changes in mean levels of serum cholesterol,
creatinine, neutrophils and platelets over time with
deucravacitinib treatment.
Additional data will also be presented from Bristol Myers
Squibb’s immunology pipeline, including iberdomide and BMS-986256
(TLR7/8 inhibitor) data in lupus and CC-99677 (MK2 inhibitor) data
in ankylosing spondylitis, psoriasis and psoriatic arthritis. These
data reinforce Bristol Myers Squibb’s commitment to developing new
treatments for rheumatic diseases.
Bristol Myers Squibb-sponsored abstracts that will be presented
at the ACR Convergence 2021 can be found below. Complete abstracts
may be accessed online here. Visit this page on BMS.com for more
information on Bristol Myers Squibb’s scientific approach and
resources on rheumatic diseases.
Orencia Presentations
- Analysis of Abatacept Treatment Retention and Efficacy
According to Disease Duration and Treatment Line in a Real-World
Setting Author: Rieke Alten Abstract Number: 0816 Session Title: RA
- Treatments Poster I: Comparative Effectiveness, Biosimilars,
Withdrawal, & the Real World (0813-0845) Sunday, November 7,
8:30 – 10:30 a.m. EST
- Prediction of 1-Year Intravenous Abatacept Retention in
Patients with RA Using Novel Machine Learning Techniques:
Directionality and Importance of Predictors Author: Rieke Alten
Abstract Number: 1212 Session: RA - Diagnosis, Manifestations,
& Outcomes Poster III: Prediction, Biomarkers, & Treatment
Response (1196-1222) Monday, November 8, 8:30 – 10:30 a.m. EST
- Baseline Extracellular Matrix Biomarkers Predict Abatacept
Treatment Response in MTX-Naive, ACPA+ Patients with Early RA
Author: Paul Emery Abstract Number: 1225 Session: RA - Treatments
Poster II: PROs, Biomarkers, & Systemic Inflammation
(1223-1256) Monday, November 8, 8:30 – 10:30 a.m. EST
- Predicting RA Remission with Subcutaneous Abatacept Treatment
in the Real-World Setting Author: Rieke Alten Abstract Number: 1228
Session: RA - Treatments Poster II: PROs, Biomarkers, &
Systemic Inflammation (1223-1256) Monday, November 8, 8:30 – 10:30
a.m. EST
- Baseline Characteristics Predictive of Remission in Patients
with RA Following Treatment with IV Abatacept: Post Hoc Analysis of
a Real-World Observational Study Author: Rieke Alten Abstract
Number: 0821 Session: RA - Treatments Poster I: Comparative
Effectiveness, Biosimilars, Withdrawal, & the Real World
(0813-0845) Sunday, November 7, 8:30 – 10:30 a.m. EST
- Histopathological Changes in Parotid and Labial Salivary Gland
Tissue in Primary Sj�gren’s Syndrome Patients After Abatacept
Treatment Author: Uzma Nakshbandi Abstract Number: 0322 Session:
Sj�gren's Syndrome – Basic & Clinical Science Poster Saturday,
November 6, 8:30 – 10:30 a.m. EST
- Long-term Safety and Effectiveness of Abatacept Treatment in
Patients with JIA: 5-year Results from the PRCSG/PRINTO JIA
Real-World Registry Author: Hermine Brunner Abstract Number: 0245
Session: Pediatric Rheumatology - Clinical Poster I: JIA
(0241-0265) Saturday, November 6, 8:30 – 10:30 a.m. EST
- Effectiveness of Abatacept in Patients with JIA, Classified by
Category: Results from the PRCSG/PRINTO JIA Real-World Registry
Author: Daniel Lovell Abstract Number: 0243 Session: Pediatric
Rheumatology - Clinical Poster I: JIA (0241-0265) Saturday,
November 6, 8:30 – 10:30 a.m. EST
- Three-year Effectiveness in Patients with JIA Initiating
Abatacept: Results from the PRCSG/PRINTO JIA Real-World Registry
Author: Nicolino Ruperto Abstract Number: 0247 Session: Pediatric
Rheumatology - Clinical Poster I: JIA (0241-0265) Saturday,
November 6, 8:30 – 10:30 a.m. EST
- Improvement in Clinical Disease Activity and Patient-Reported
Outcomes After 6 Months of Treatment with Abatacept, Stratified by
Line of Therapy, in Patients with RA: Results from a Large, US,
National Observational Study Author: Leslie Harrold Abstract
Number: 0813 Session: RA - Treatments Poster I: Comparative
Effectiveness, Biosimilars, Withdrawal, & the Real World
(0813-0845) Sunday, November 7, 8:30 – 10:30 a.m. EST
- Does BMI Influence the Efficacy of Subcutaneous or Intravenous
Abatacept in Patients with RA in Routine Clinical Practice? A Post
Hoc Analysis of Two Real-World Observational Studies Author: Rieke
Alten Abstract Number: 1229 Session: RA - Treatments Poster II:
PROs, Biomarkers, & Systemic Inflammation (1223-1256) Monday,
November 8, 8:30 – 10:30 a.m. EST
Orencia Health Economics and Outcomes Research (HEOR)
Presentations
- Treatment Persistence Among Medicare Beneficiaries with
Seropositive Rheumatoid Arthritis Initiating Biologic or Targeted
Synthetic DMARDs Author: Sang Hee Park Abstract Number: 0463
Session: Abstracts: Health Services Research (0462-0465) Saturday,
November 6, 10:30 – 11:30 a.m. EST Oral Presentation
- Examining the Relationship Between Shared Epitope, ACPA
Seropositivity, and Real-World Drug Effectiveness in Patients with
Rheumatoid Arthritis Author: Kristin Wipfler Abstract Number: 1214
Session: RA - Diagnosis, Manifestations, & Outcomes Poster III:
Prediction, Biomarkers, & Treatment Response (1196-1222)
Monday, November 8, 8:30 – 10:30 a.m. EST
- Disparities in Burden of Disease in Patients with RA Across
Racial and Ethnic Groups Author: Jacqueline O’Brien Abstract
Number: 0604 Session: Healthcare Disparities in Rheumatology Poster
(0594-0622) Sunday, November 7, 8:30 – 10:30 a.m. EST
- Adjusted Analyses of the Benefits of Autoantibody Enrichment on
Efficacy Outcomes in Early RA, from a Pooled Analysis of 4
Abatacept RCTs Author: Janet Pope Abstract Number: 1248 Session: RA
- Treatments Poster II: PROs, Biomarkers, & Systemic
Inflammation (1223-1256) Monday, November 8, 8:30 – 10:30 a.m.
EST
- Consistent Impact of Autoantibody Enrichment Across all ACR
Core Measures in Early Rheumatoid Arthritis Treated with Abatacept:
Data from a Large Pooled Analysis of 4 Randomized Controlled Trials
Author: Philip Conaghan Abstract Number: 1231 Session: RA -
Treatments Poster II: PROs, Biomarkers, & Systemic Inflammation
(1223-1256) Monday, November 8, 8:30 – 10:30 a.m. EST
- Construction of the Veterans Affairs National Rheumatoid
Arthritis Database (VANRAD) Author: Amy Joseph Abstract Number:
0568 Session: Epidemiology & Public Health Poster II:
Inflammatory Arthritis - RA, SpA, & Gout (0560-0593) Sunday,
November 7, 8:30 – 10:30 a.m. EST
Deucravacitinib Presentations
- Biomarker Changes with Selective Tyrosine Kinase 2 Inhibitor,
Deucravacitinib, in PsA: Effects on Disease Markers and Tyrosine
Kinase 2‒ Versus Janus Kinase 1/2/3‒Mediated Pathways Author:
Oliver Fitzgerald Abstract Number: 0490 Session Title: Abstracts:
Spondyloarthritis Including PsA – Treatment I: Emerging Therapies
(0488–0491) Saturday, November 6, 2:00 – 3:00 p.m. EST Oral
Presentation
- The Impact of Deucravacitinib on Health-Related Quality of Life
Measured by the Short Form Health Survey 36-Item Questionnaire:
Analysis of a Phase 2 Trial in Patients with Active PsA Author:
Vibeke Strand Abstract Number: 0232 Session Title: Patient
Outcomes, Preferences, & Attitudes Poster I: Impact (0225–0240)
Saturday, November 6, 8:30 – 10:30 a.m. EST
- Deucravacitinib Efficacy in Psoriatic Arthritis (PsA) by
Baseline DMARD Use: Exploratory Analysis from a Phase 2 Study
Author: Atul Deodhar Abstract Number: 1352 Session Title:
Spondyloarthritis Including PsA - Treatment Poster II: Psoriatic
Arthritis I (1329–1363) Monday, November 8, 8:30 – 10:30 a.m.
EST
- Selective Inhibition of Tyrosine Kinase 2 With Deucravacitinib
Compared with Janus Kinase 1/2/3 Inhibitors Author: Anjaneya
Chimalakonda Abstract Number: 0509 Session Title: Cytokines &
Cell Trafficking Poster (0508-0516) Sunday, November 7, 8:30 –
10:30 a.m. EST
- Effect of Deucravacitinib on the Psoriatic Arthritis Impact of
Disease Questionnaires 12 and 9: Analysis of a Phase 2 Study of
Active Psoriatic Arthritis Author: Laure Gossec Abstract Number:
0750 Session Title: Patient Outcomes, Preferences, & Attitudes
Poster II: Measurements (0739-0763) Sunday, November 7, 8:30 –
10:30 a.m. EST
- Efficacy of Deucravacitinib, an Oral, Selective Tyrosine Kinase
2 Inhibitor, in Musculoskeletal Manifestations of Active PsA in a
Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial Author:
Philip Mease Abstract Number: 1820 Session Title: Spondyloarthritis
Including PsA - Treatment Poster III: Psoriatic Arthritis II
(1801-1835) Tuesday, November 9, 8:30 – 10:30 a.m. EST
Iberdomide Presentation
- Sustained Efficacy and Safety of Iberdomide to Week 52 in
Patients with Active Systemic Lupus Erythematosus (SLE) in a Phase
2, Randomized, Placebo-Controlled Study Author: Joan Merrill
Abstract Number: 1458 Session Title: SLE - Treatment: New Agents,
Old Agents (1458-1463) Monday, November 8, 3:30 – 5:00 p.m. EST
Oral Presentation
MK2i Presentations
- CC-99677: a Novel, Oral, Selective MK2 Inhibitor with
Sustainable Multi-Cytokine Inhibition for the Treatment of
Ankylosing Spondylitis and Other Inflammatory Diseases Author: Kofi
Mensah Abstract Number: 0489 Session Title: Abstracts:
Spondyloarthritis Including PsA - Treatment I: Emerging Therapies
(0488-0491) Saturday, November 6, 2:00 – 3:00 p.m. EST Oral
Presentation
- CC-99677, a Novel, Selective, Oral MK2 Inhibitor, Sustainably
Reduces Pro-Inflammatory Cytokine Production and Ameliorates
Inflammation in the Mannan-Induced Murine Model of Psoriasis and
Psoriatic Arthritis Author: Rajula Guar Abstract Number: 0049
Session Title: Spondyloarthritis Including PsA - Basic Science
Poster (0046-0068) Saturday, November 6, 8:30 – 10:30 a.m. EST
TLR7/8 Presentations
- Inhibition of Toll-Like Receptor 7 (TLR7) with the Potent and
Selective Inhibitor of Human TLR7 and TLR8 BMS-986256 Provides
Robust Efficacy in Murine Lupus Models, Reversing Established
Disease Author: Shailesh Dudhgaonkar Abstract Number: 0470 Session
Title: Abstracts: SLE - Animal Models (0470-0473) Saturday,
November 6, 11:00 – 12:00 p.m. EST Oral Presentation
- First-in-Human Safety, Pharmacokinetic and Pharmacodynamic
Study of Escalating Single- and Multiple-Doses of BMS-986256, a
Novel, Potent, Oral Inhibitor of TLR7 and TLR8 Author: Melanie
Harrison Abstract Number: 1771 Session Title: SLE – Treatment
Poster (1732-1772) Tuesday, November 9, 8:30 – 10:30 a.m. EST
- BMS-986256, an Oral Novel Toll-like Receptor 7 and 8 (TLR7/8)
Inhibitor, does not Affect the Pharmacokinetics of Mycophenolate
Mofetil in Healthy Subjects Author: Manoj Chiney Abstract Number:
1769 Session Title: SLE – Treatment Poster (1732-1772) Tuesday,
November 9, 8:30 – 10:30 a.m. EST
About Psoriatic Arthritis
Psoriatic arthritis is a chronic, immune-mediated, heterogenous
disease with multiple musculoskeletal and skin manifestations,
including inflammatory arthritis, enthesitis (which occurs when the
connective tissue between tendons or ligaments and bone called
enthesis becomes inflamed), dactylitis (inflammation and swelling
of the fingers and toes), spinal inflammation and psoriatic skin
and nail lesions. Up to 42 percent of patients with psoriasis may
develop psoriatic arthritis. In addition to the loss of physical
function, pain and fatigue caused by psoriatic arthritis, the
disease can significantly impact the mental and emotional
well-being of patients. Additionally, patients with psoriatic
arthritis are at increased risk of developing serious
comorbidities, including cardiovascular disease, metabolic syndrome
and depression, as well as extraarticular manifestations of
disease, such as inflammatory bowel disease.
About Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a destructive immune-mediated
disease of the joints characterized by inflammation in the joint
lining (or synovium), leading to joint damage with chronic pain,
stiffness and swelling. RA causes limitations in range of motion
and decreased joint function with long-term disability. Women are
three times more likely than men to develop RA.
About Lupus
Lupus is a chronic, complex immune-mediated disease that results
in the immune system attacking multiple organs in the body. Lupus
most often affects the joints, skin, kidneys, blood vessels, blood
cells, brain and lungs, causing widespread inflammation and tissue
damage in the affected organ(s). There are more than five million
people around the world with a form of lupus, and it is most often
diagnosed in young women between the ages of 15 and 44. The most
common type of lupus is systemic lupus erythematosus (SLE), which
accounts for approximately 70 percent of all lupus cases. Within
five years of disease onset, 40-60 percent of patients with SLE
develop lupus nephritis (renal involvement), the most important
predictor of SLE morbidity and mortality.
About Deucravacitinib
Deucravacitinib (pronounced doo-krav-a-sih-ti-nib) is a
first-in-class, oral, selective tyrosine kinase 2 (TYK2) inhibitor
with a unique mechanism of action and is the first and only
selective TYK2 inhibitor in clinical studies across multiple
immune-mediated diseases. Bristol Myers Squibb scientists designed
deucravacitinib to selectively target TYK2, thereby inhibiting
signaling of interleukin (IL)-23, IL-12 and Type 1 interferon
(IFN), key cytokines involved in the pathogenesis of multiple
immune-mediated diseases. Deucravacitinib achieves a high degree of
selectivity by binding to the regulatory domain of TYK2, resulting
in allosteric inhibition of TYK2 and its downstream functions.
Deucravacitinib selectively inhibits TYK2, unlike approved Janus
kinase (JAK) 1, 2 and 3 inhibitors, at physiologically relevant
concentrations. At therapeutic doses, deucravacitinib does not
inhibit JAK1, JAK2 or JAK3.
Deucravacitinib is being studied in multiple immune-mediated
diseases, including psoriasis, psoriatic arthritis, lupus and
inflammatory bowel disease. Deucravacitinib is not approved for use
in any country.
About ORENCIA
Orencia is an immunomodulator that disrupts the continuous cycle
of T-cell activation that characterizes RA, psoriatic arthritis and
juvenile idiopathic arthritis (JIA). In RA, Orencia targets unique
and fundamental drivers of the disease, resulting in improved
efficacy and durability in seropositive RA patients (patients with
key biomarkers of the disease). Approved for RA by the FDA in 2005
and by the European Commission in 2007, Orencia is an established
treatment with a proven safety profile across the disease
continuum.
U.S. Indications/Usage and Important Safety Information for
ORENCIA® (abatacept)
Indications and Usage
Adult Rheumatoid Arthritis: ORENCIA® (abatacept) is
indicated for the treatment of adult patients with moderately to
severely active rheumatoid arthritis (RA).
Polyarticular Juvenile Idiopathic Arthritis: ORENCIA is
indicated for the treatment of patients 2 years of age and older
with moderately to severely active polyarticular juvenile
idiopathic arthritis (pJIA).
Adult Psoriatic Arthritis: ORENCIA is indicated for the
treatment of adult patients with active psoriatic arthritis
(PsA).
Limitations of Use: The concomitant use of ORENCIA with
other potent immunosuppressants [e.g., biologic disease-modifying
antirheumatic drugs (bDMARDS), Janus kinase (JAK) inhibitors] is
not recommended.
Important Safety Information for ORENCIA® (abatacept)
Concomitant Use with TNF Antagonists, Other Biologic RA/PsA
Therapy, or JAK Inhibitors: Concurrent therapy with ORENCIA and
a TNF antagonist is not recommended. In controlled clinical trials,
adult RA patients receiving concomitant intravenous ORENCIA and TNF
antagonist therapy experienced more infections (63% vs 43%) and
serious infections (4.4% vs 0.8%) compared to patients treated with
only TNF antagonists, without an important enhancement of efficacy.
Additionally, concomitant use of ORENCIA with other biologic RA/PsA
therapy or JAK inhibitors is not recommended.
Hypersensitivity: There were 2 cases (<0.1%; n=2688)
of anaphylaxis reactions in clinical trials with adult RA patients
treated with intravenous ORENCIA. Other reactions potentially
associated with drug hypersensitivity, such as hypotension,
urticaria, and dyspnea, each occurred in <0.9% of patients.
There was one case of a hypersensitivity reaction with ORENCIA in
pJIA clinical trials (0.5%; n=190). In postmarketing experience,
fatal anaphylaxis following the first infusion of ORENCIA and
life-threatening cases of angioedema have been reported. Angioedema
has occurred as early as after the first dose of ORENCIA, but also
has occurred with subsequent doses. Angioedema reactions have
occurred within hours of administration and in some instances had a
delayed onset (i.e., days). Appropriate medical support measures
for treating hypersensitivity reactions should be available for
immediate use. If an anaphylactic or other serious allergic
reaction occurs, administration of intravenous or subcutaneous
ORENCIA should be stopped immediately and permanently discontinued,
with appropriate therapy instituted.
Infections: Serious infections, including sepsis and
pneumonia, were reported in 3% and 1.9% of RA patients treated with
intravenous ORENCIA and placebo, respectively. Some of these
infections have been fatal. Many of the serious infections have
occurred in patients on concomitant immunosuppressive therapy
which, in addition to their underlying disease, could further
predispose them to infection. Caution should be exercised in
patients with a history of infection or underlying conditions which
may predispose them to infections. Treatment with ORENCIA should be
discontinued if a patient develops a serious infection. Patients
should be screened for tuberculosis and viral hepatitis in
accordance with published guidelines, and if positive, treated
according to standard medical practice prior to therapy with
ORENCIA.
Immunizations: Prior to initiating ORENCIA in pediatric
and adult patients, update vaccinations in accordance with current
vaccination guidelines. Live vaccines should not be given
concurrently with ORENCIA or within 3 months after discontinuation.
ORENCIA may blunt the effectiveness of some immunizations.
Use in Patients with Chronic Obstructive Pulmonary Disease
(COPD): In Study V, adult COPD patients treated with ORENCIA
for RA developed adverse events more frequently than those treated
with placebo, including COPD exacerbations, cough, rhonchi, and
dyspnea. In the study, 97% of COPD patients treated with ORENCIA
developed adverse events versus 88% treated with placebo.
Respiratory disorders occurred more frequently in patients treated
with ORENCIA compared to those on placebo (43% vs 24%,
respectively), including COPD exacerbation, cough, rhonchi, and
dyspnea. A greater percentage of patients treated with ORENCIA
developed a serious adverse event compared to those on placebo (27%
vs 6%), including COPD exacerbation [3 of 37 patients (8%)] and
pneumonia [1 of 37 patients (3%)]. Use of ORENCIA in patients with
COPD should be undertaken with caution, and such patients monitored
for worsening of their respiratory status.
Immunosuppression: In clinical trials in adult RA
patients, a higher rate of infections was seen in ORENCIA-treated
patients compared to placebo-treated patients. The impact of
treatment with ORENCIA on the development and course of
malignancies is not fully understood. There have been reports of
malignancies, including skin cancer in patients receiving ORENCIA.
Periodic skin examinations are recommended for all ORENCIA-treated
patients, particularly those with risk factors for skin cancer.
Blood Glucose Testing: ORENCIA for intravenous administration
contains maltose, which may result in falsely elevated blood
glucose readings on the day of infusion when using blood glucose
monitors with test strips utilizing glucose dehydrogenase
pyrroloquinoline quinone (GDH-PQQ). Consider using monitors and
advising patients to use monitors that do not react with maltose,
such as those based on glucose dehydrogenase nicotine adenine
dinucleotide (GDH-NAD), glucose oxidase or glucose hexokinase test
methods. ORENCIA for subcutaneous (SC) administration does not
contain maltose; therefore, patients do not need to alter their
glucose monitoring.
Pregnancy: There are no adequate and well-controlled
studies of ORENCIA use in pregnant women and the data with ORENCIA
use in pregnant women are insufficient to inform on drug-associated
risk. A pregnancy registry has been established to monitor
pregnancy outcomes in women exposed to ORENCIA during pregnancy.
Healthcare professionals are encouraged to register patients by
calling 1-877-311-8972.
Lactation: There is no information regarding the presence
of abatacept in human milk, the effects on the breastfed infant, or
the effects on milk production. However, abatacept was present in
the milk of lactating rats dosed with abatacept.
Most Serious Adverse Reactions: Serious infections (3%
ORENCIA vs 1.9% placebo) and malignancies (1.3% ORENCIA vs 1.1%
placebo).
Malignancies: The overall frequency of malignancies was
similar between adult RA patients treated with ORENCIA or placebo.
However, more cases of lung cancer were observed in patients
treated with ORENCIA (0.2%) than those on placebo (0%). A higher
rate of lymphoma was seen compared to the general population;
however, patients with RA, particularly those with highly active
disease, are at a higher risk for the development of lymphoma. The
potential role of ORENCIA in the development of malignancies in
humans is unknown.
Most Frequent Adverse Events (≥10%): Headache, upper
respiratory tract infection, nasopharyngitis, and nausea were the
most commonly reported adverse events in the adult RA clinical
studies. Other events reported in ≥5% of pJIA patients were
diarrhea, cough, pyrexia, and abdominal pain. In general, the
adverse events in pediatric pJIA and adult PsA patients were
similar in frequency and type to those seen in adult RA
patients.
Note concerning ORENCIA administration options: ORENCIA
may be administered as an intravenous infusion only for patients 6
years of age and older. PJIA patients may self-inject with ORENCIA
or the patient’s caregiver may administer ORENCIA if both the
healthcare practitioner and the parent/legal guardian determines it
is appropriate. The ability of pediatric patients to self-inject
with the autoinjector has not been tested.
Please click here for Full Prescribing Information.
Bristol Myers Squibb: Pioneering Paths Forward in Immunology
to Transform Patients’ Lives
Bristol Myers Squibb is inspired by a single vision –
transforming patients’ lives through science. For people living
with immune-mediated diseases, the debilitating reality of enduring
chronic symptoms and disease progression can take a toll on their
physical, emotional and social well-being, making simple tasks and
daily life a challenge. Driven by our deep understanding of the
immune system that spans over 20 years of experience, and our
passion to help patients, the company continues to pursue
pathbreaking science with the goal of delivering meaningful
solutions that address unmet needs in rheumatology,
gastroenterology, dermatology and multiple sclerosis. We follow the
science, aiming to tailor therapies to individual needs, improve
outcomes and expand treatment options by working to identify
mechanisms with the potential to achieve long-term remission – and
perhaps even cures – in the future. By building partnerships with
researchers, patients and caregivers to deliver innovative
treatments, Bristol Myers Squibb strives to elevate patient care to
new standards and deliver what matters most – the promise of living
a better life.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose
mission is to discover, develop and deliver innovative medicines
that help patients prevail over serious diseases. For more
information about Bristol Myers Squibb, visit us at BMS.com or
follow us on LinkedIn, Twitter, YouTube, Facebook and
Instagram.
Celgene and Juno Therapeutics are wholly owned subsidiaries of
Bristol-Myers Squibb Company. In certain countries outside the
U.S., due to local laws, Celgene and Juno Therapeutics are referred
to as, Celgene, a Bristol Myers Squibb company and Juno
Therapeutics, a Bristol Myers Squibb company.
Cautionary Statement Regarding Forward-Looking
Statements
This press release contains “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of 1995
regarding, among other things, the research, development and
commercialization of pharmaceutical products. All statements that
are not statements of historical facts are, or may be deemed to be,
forward-looking statements. Such forward-looking statements are
based on historical performance and current expectations and
projections about our future financial results, goals, plans and
objectives and involve inherent risks, assumptions and
uncertainties, including internal or external factors that could
delay, divert or change any of them in the next several years, that
are difficult to predict, may be beyond our control and could cause
our future financial results, goals, plans and objectives to differ
materially from those expressed in, or implied by, the statements.
These risks, assumptions, uncertainties and other factors include,
among others, that future study results will be consistent with the
results to date, that the treatments, including deucravacitinib and
Orencia, may not receive regulatory approval for the indications
described in this release, any marketing approvals, if granted, may
have significant limitations on their use, and, if approved,
whether such treatments for such indications described in this
release will be commercially successful. No forward-looking
statement can be guaranteed. Forward-looking statements in this
press release should be evaluated together with the many risks and
uncertainties that affect Bristol Myers Squibb’s business and
market, particularly those identified in the cautionary statement
and risk factors discussion in Bristol Myers Squibb’s Annual Report
on Form 10-K for the year ended December 31, 2020, as updated by
our subsequent Quarterly Reports on Form 10-Q, Current Reports on
Form 8-K and other filings with the Securities and Exchange
Commission. The forward-looking statements included in this
document are made only as of the date of this document and except
as otherwise required by applicable law, Bristol Myers Squibb
undertakes no obligation to publicly update or revise any
forward-looking statement, whether as a result of new information,
future events, changed circumstances or otherwise.
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